The process of collecting cardiac safety electrocardiogram (ECG) data in clinical trials is stuck in the past. Too often, site personnel must rely on bulky ECG machines that collect results and submit them in batches, manage paper records, and perform manual data selection. All this creates roadblocks and opens the door to human error and the kinds of site queries that grind progress to a halt. This often happens because legacy core labs are heavily invested in technologies that are less than efficient when it comes to managing and sharing results. This creates a lack of integration and subsequent inefficiencies. Trial sponsors may still get the results they need, but it is often a time—and labor—intensive process for research personnel.

Fortunately, there is a better way to work. Modern technology can empower site personnel to cut errors, reduce queries, and work more efficiently. Why does that matter? Because research has repeatedly shown that happy workers are more productive. For research site personnel, that may mean they’re more likely to go the extra mile—collect more accurate data, enroll more participants, and provide better information. Here are four factors to consider as you evaluate technology and partners for your next cardiac safety trial:

 In the typical clinical trial, site personnel enter patient information at each visit. Mistyping a patient’s ID number or incorrectly noting which visit the patient is making requires core lab employees to verify that information, potentially leading to hours or days of back-and-forth calls or emails. Technology that integrates visit schedules, subject demographics, and ECG acquisition data; however, allows site personnel to collect demographic information only once. From there, the system can track which visit a patient is making and connect their data to the proper ID. This level of integration enables the collection of up-to-the-minute enrollment visit data, while providing customizable reports directly to partner systems. And, most importantly, it reduces the potential for human error.

 With a centralized system, by contrast, everything is stored electronically, so reviewing an anomaly is as easy as logging in. Ideally, ECG systems will offer role-based access to data, so everyone can view the information they need regardless of location. Centralized data also allows for immediate ECG review and confirmation, ensuring ECG quality and compliance for sites and enabling decisions on inclusion in near real time. In addition, because data changes hands less often, higher levels of security can be maintained.

 Although ECG research is highly technical, the actual data collection process is often manual. Site personnel get patients settled, wait for them to calm down, then hit a button to collect a resting ECG. But if the patient moves in the instant the button is pressed, the signal can get scrambled and the process starts over. That’s inconvenient for site staff and participants, and it means there will be multiple ECGs for that patient in the buffer, requiring the core lab to verify which data to submit. By contrast, algorithm-based tools allow sites to record up to 20 minutes of ECG data, then either select the best 10 seconds or allow the computer to choose for them.

 Traditional ECG machines aren’t just inefficient in the way they collect and transmit data. At a time when ECG technology is showing up in watches and necklaces, the devices used in most cardiac safety trials are anything but wearable. A reliance on physical records means machines need to be large enough to include a printer, and paper feed. As a result, machines are bulky, and a site that manages multiple trials can quickly fill closets with equipment dedicated to various sponsors. More sophisticated options, meanwhile, connect ECG leads to powerful tablet computers to collect data. The touch screens put information at users’ fingertips, while modern computing tools offer advanced capabilities in a compact package that is easier to carry and store.

Advances in ECG acquisition technology improve speed, accuracy, compliance, and data security. Working with digital data throughout the process ensures information won’t be recorded under the wrong name, or that paper records won’t be accidentally filed in the wrong place. It’s a defense against human error, in other words. In the long run, that means research sponsors can reduce queries and help research sites achieve better results, in less time, and with significantly less frustration.

Articles

A Closing Thought

Tips for reducing site queries and improving workflows.

Better Cardiac Safety Trials

Issue PDF

Click the title above for a link to open the Applied Clinical Trials September 2020 issue in an interactive PDF format.

Applied Clinical Trials, October 2020 Issue (PDF)

In the face of the pandemic, more coronavirus clinical trials are being planned and initiated, while a large number of studies for non-COVID-19 indications are suffering delays. Much of the disruption can be attributed to measures taken to ensure patient safety, such as strict lockdowns and social distancing, as well as the high demand for medical professionals to treat and manage COVID-19 patients.

Across the clinical research community, we’re seeing a direct impact on trial site activation and patient enrollment. Many investigative sites are either being reallocated to assist in front-line COVID-19 care or have been temporarily closed, with much of their staff presently furloughed, making it harder for existing, pre-pandemic trials to continue. Consequently, many sponsors have implemented alternative ways to conduct trials or components of them, incorporating remote and virtual activities, which aim to bring studies directly to patients via a range of technologies.

While the pandemic has presented the industry with a host of operational challenges, COVID-19 has also given us the opportunity to reflect on how we can improve the clinical trial experience.

A focus on better understanding patients’ journeys through the clinical trial process and their interactions with investigative sites in the midst of the coronavirus crisis has prompted an important question: How can sponsors set up sites for success in a post COVID-19 world?

The answer largely lies in addressing existing pain points for investigative sites, pain points that predated the pandemic, including those around protocol development, staffing, payment schedules and, last but not least, patient engagement.

A true partnership between sponsors and investigative sites must emerge that prioritizes proactive planning and listening, enabling the development of solutions that allow critical clinical trial work to not only continue, but expand, accelerate, and thrive.

Whether independent or an academic medical center, investigative sites have long been asking for changes to overcome the many pain points that delay or hamper clinical research. Essentially, these are old problems, but now they present themselves with a new twist because of COVID-19 and there is an impression that the issues are completely different from those clinical trial sites have always faced.

For example, sponsors notoriously leave sites out of protocol development, which we are well aware of in the industry. Every clinical investigation begins with the development of a protocol that describes how a clinical trial will be conducted—encompassing the objective(s), design, methodology, statistical considerations, and organization of the study—and ensures the safety of the trial subjects and integrity of the data collected. These documents are already quite complex, and now amid the pandemic, sites are expected to add requirements like negative COVID-19 tests as a prerequisite for patient participation and to do so without any support from trial sponsors.

Being left to navigate new requirements and complexities, and somehow still find the right patients for a clinical study is not an entirely new challenge for sites. We often hear sites say things along the lines of: “this inclusion/exclusion criteria is going to yield zero patients because we can’t find patients who meet the protocol requirements,” whether, for example, that is a specific cholesterol test or body mass index (BMI). Rather than expecting sites to just ‘figure it out” on their own, sponsors must focus on optimizing protocol design by better matching the right types of sites with the right types of studies (e.g., institutions for oncology vs. independent sites for vaccines).

Similarly, staffing challenges at clinical trial sites have always been a source of frustration, but amid the pandemic, these frustrations are being heightened. Where studies went on hold, new COVID-19 treatment and vaccine trials continue to start and, more recently, non-COVID-19 studies are ramping up again. Many independent sites, as well as academic institutions that conduct trials, suffer from staffing bottlenecks, which are intensifying because of COVID-19. For already overloaded study coordinators, who generally are without the support of a dedicated team or on-site resources, the workload has increased to a point where it has become nearly impossible to manage without additional support from service providers.

An increasing number of independent sites are offloading administrative functions so that their staff can concentrate on more clinically-focused activities. However, while independent sites are scrambling to do this quickly, larger institutions are unable to pivot and adapt at the same pace. Particularly in urban areas where hospitals are doing all they can to stay afloat, many studies have been put on the backburner and research team members, such as trial nurses, have been reassigned to help manage everyday healthcare needs, including those that involve COVID-19 triage.

That said, where staffing for clinical studies continues to be prioritized within hospital settings are cases in which research is the only care option for patients who are terminally ill, such as those enrolled in certain oncology trials.

COVID-19’s impact on clinical trial sites is much more nuanced than simply stating “the study went on hold.” A giant pain point has to do with the fact that many sites, particularly hospitals, are struggling financially. Elective and other non-essential procedures and surgeries are still a challenge to schedule and perform because of the coronavirus. This leaves hospitals and other investigative sites with the bleak reality of having to deal with reduced profitability and, consequently, furloughs, a slimmed-down staff, and even less flexibility to leverage service providers for resourcing needs.

Financial stress is a well-known challenge to clinical research site success and, again, the pandemic has simply exacerbated this pain point. Limited operating cash, manual invoicing processes, untimely payment frequency, and lack of financial transparency negatively impact site engagement and, for the most part, stem from antiquated payment terms and triggers. Investing in technologies and processes that ensure payments are accurate and on time will go a long way to resolving these issues and improving site productivity. Additionally, rather than using payment “holdbacks,” sponsors can employ alternative methods, such as better and more transparent monitoring plans to hold sites accountable for resolutions to queries.

Effectively tackling the industry-wide issue of delays in the execution of clinical trial agreements (CTAs) between sponsors or their CRO partners and sites is another measure that can be taken to meet the needs of sites in a post-COVID-19 world. Currently, we’ve seen a 10% increase globally and 13% increase in the U.S. to finalize a CTA for large research institutions. What’s interesting is that independent sites have seen a decline in the overall time of negotiations (for all trial types). Furthermore, most COVID-19 CTA negotiations are completed in less than a week, when the typical timeframe for non-COVID-19 trials can be more than three months. These differences between trial and site types need to be captured in sponsors’ templates and expectations. Standardizing legal language and streamlining the process with solutions—which address the needs of both independent sites that have limited legal resources and academic institutions more concerned with IP, indemnification, and government funding requests—would speed up study start-up by weeks, if not months.

The urgency around developing treatments and vaccines for COVID-19 has also made it clear that existing technologies can be better leveraged to address trial inefficiencies, reduce the burden on both patients and sites, and accelerate progress in clinical development. As a result of the pandemic, we will see more hybrid trials that combine site and remote patient visits. More clinical trial protocols will be written with decentralization in mind, as sponsors have now seen first-hand how positively sites have responded to working with technologies—such as telehealth tools, electronic patient-reported outcomes, and wearables, for example—that enable this approach and simultaneously reduce the burden on sites and their patients.

The decentralization of clinical trials, of course, comes along with challenges for investigative sites as well. Putting new standard operating procedures and processes in place for the conduct of remote visits adds complexity, as does incorporating and adjusting to technology designed to support them and improved patient engagement and retention. Again, at their core, these are not inherently new challenges, but the pandemic has provided an opportunity to revisit our approach to tackling pain points. In forcing the research community to be more open to using different tools to ensure vital research continues, the pandemic is driving the beginning of a new era of patient and site engagement—one in which a more proactive and efficient approach ensures the lines of communication remain open and data is collected appropriately and with greater speed.

On the flip side, sponsors will need to carefully manage which and how many technology tools they ask investigative sites to use in a given research study. Imagine a site with 10 studies from different sponsors and how many different technologies and systems they need to learn how to use in order to be successful. That problem only gets compounded as a site runs more trials for more sponsors, and some sites have as many as 400 studies ongoing at once. What it comes down to, in this case, is less is generally more. Investing in best-in-class technologies that are consistently and more commonly used across the industry, rather than customized systems, will reduce the burden on sites, especially as the disruption caused by the pandemic lessens and the volume of non-COVID-19 trials increases.

Finally, with the more open mindset the pandemic has brought about, sponsors should be more willing to use new sites for different indications. The decreasing number of primary investigators conducting research means we cannot only rely on sites we have worked with previously. Sponsors and CROs must embrace research-naïve sites in order to hit FPI (“first patient in”) and enrollment goals.

Additionally, to ensure patients in clinical trials are representative of the population, an emphasis must be placed on diversity. We know this is an issue today, so we must do all we can to introduce new sites into the mix, in locations that represent the demographic diversity of the populations we aim to serve. In doing so, we will help to move the needle and meaningfully improve outcomes for more and more patients.

Vice President, WCG Study Start-Up & Administration, 

Feature Articles

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success. 

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

The COVID-19 pandemic has been a lengthy, and uncomfortable pressure test for our global healthcare system. In the long term, we hope that 2020 will prove to be an inflection point for positive change, an urgent call to action to address the bottlenecks that have gotten in the way of a more efficient and effective way of improving human health. In the short-term, however, there have been more immediate and acute concerns about the ability of clinical development to continue in the face of widespread infection; how will patients continue participation when leaving home poses a significant risk?; what happens to patients who are relying on speedy development of life-changing, even life-saving, treatments? 

As clinical trial sponsors faced unprecedented roadblocks, many quickly realized that speed and agility would be key if they were to steer their way through COVID-19 and ensure that research, discovery, and patient care were not completely obstructed. One critical area of focus was maintaining a strong site relationship strategy, and as countries move beyond the initial disruption of lockdowns, it is clear that the lessons learned in this area will be critical for ongoing efficiency and productivity in the “new normal.”

Without a doubt, the pandemic experience has exposed a number of shortcomings, some directly related to the current situation, but others more systemic. The subsequent assessment has left some sponsors reimagining what strong site relationship strategies in the future may (or rather, should) entail.

An effective and agile site strategy starts with viewing trial sites as valued partners throughout the entire clinical development process, not just a single stop on the way. By maintaining deep, ongoing relationships with sites and their patients, sponsors and their clinical research partners are able to quickly incorporate innovative approaches to adapting to obstacles at hand, like COVID-19, or increase efficiencies within the trial process.

It can be extremely valuable to categorize sites based on several partner factors to determine optimal ways and times to consider involving them in trials of interest. In a sense, this can position sponsors to assess their “go-to” site networks based on needs as they arise.

 An elite clinical trial institute or site network has a long-standing relationship with the sponsor and CRO, with each heavily dedicated to ensuring growth and pushing innovation through mutually agreed upon key performance indicators. Such elite networks often work across multiple therapeutic areas or in singular, but high-volume therapeutic spaces and go above and beyond industry benchmarks to meet a trial’s requirements. In some cases, sponsors and sites have dedicated relationship managers to oversee and grow the alliance, ensure quality delivery of various trials within the portfolio, and continuously seek new opportunities to collaborate further. For some organizations, including IQVIA, these institutions are already informed and fully engaged in leveraging our tech-enabled solutions and data insights to meet our customers’ key study deliverables.

 On another level, sponsors and CROs may partner with a research institution or site network with a proven track record of quality performance in managing studies and the ability to meet anticipated needs within varying therapeutic spaces. They may have some experience with a sponsor or CROs’ solutions, but will work to perform at or above industry standards for varying trial needs, such as site start-up and recruitment. And therapeutic sites can continue to expand research capabilities to include additional specialties. The history between site and sponsor can organically help with that expansion.

 Lastly, it is essential to develop therapeutic network strategies in specialist areas, such as rare disease and cell and gene therapy. These networks work with expert sites and investigators in a specialized field to ensure the appropriate capabilities are in place to meet the trial and patient needs.

In these times, we see how strategically important it is for sponsors to maintain several diverse partnerships to maintain trial continuity for patients in need.

As some countries experience resurgences in COVID-19, some sites may need to close or make quick changes over the coming months. It is helpful for sponsors to adjust quickly by knowing what sites they can turn to and keep trials on track. In a long-term strategy, sponsors need to anticipate challenges in their pipeline programs and address them with foresight. Maintaining diverse partnerships can help match up trial needs with individual site capabilities, as part of a proactive strategy.

Enhancing patient-to-trial matching capabilities

In traditional clinical development, investigators guide patient recruitment. During the initial months of the pandemic, when almost every aspect of clinical development was on hold, patient recruitment proved to be a tremendous concern for sponsors. With patient interest in trials increasing, it was essential to carve another path to reach them and connect them to trials.

As an example, to optimize patient recruitment, IQVIA uses a layered approach, efficiently utilizing our relationships with partner sites. First, recruitment starts with sites that have strong, comprehensive patient databases. These sites are highly qualified research sites. Because of the access to large numbers of potentially qualified patients onsite, staffing levels may be a limited concern in quickly contacting and qualifying patients within its systems.

To secure additional patients, we also rely on proprietary healthcare data assets and modeling algorithms using artificial intelligence and machine learning to create a direct-to-patient recruitment model. This approach allows sponsors to aid sites with recruitment by providing additional qualified patients for ongoing trials from our trial matching capabilities. By broadening the identification of patients beyond the site’s database, we are able to rapidly recruit participants and execute hyper-targeted multi-channel campaigns (e.g., social media, pharmacies, labs, patient communities, etc.) to also raise awareness of trials in their local markets. Delivering the right message at the right time is a key component of this model, which can be a productive way to engage patient populations quickly during downtimes and with limited resources.

To keep up with the potential volume of patients for ongoing trials, it is important to maintain the appropriate staffing levels when multiple protocols are enrolling at the same time. During the pandemic, maintaining appropriate staffing became a challenge for some sites. In these cases, qualified research staff were assigned to work at the direction of the principal investigator. Augmenting the staffing model played a key role in accelerating recruitment.

As sites reopened and targeted patients opted-in for participation, it was useful for sponsors to consider relying on the expertise of the global site network teams to provide experienced study support to reduce site burden and continue high-quality patient care throughout the trial.

Also, during the pandemic, routine patient visits with their providers decreased due to their own safety concerns and restricted access to critical patients only. The reduced patient volumes and corresponding billing reduction led many sites to furlough staff and/or reduce staff numbers and hours, creating more trial onboarding delays.

Another creative way IQVIA dealt with these delays was to re-engage furloughed site staff using sponsor funding, and temporarily engaging these staff through the global site network infrastructure to return and focus on specific protocol tasks.

This sponsor-funded approach allowed study sites to retain/bring back trained employees who know the appropriate trial protocols and steps to reduce onboarding time. By working with sites to augment staffing, sponsors know that trials remain on track despite roadblocks. If sites were bringing in new staff, these individuals would need to be trained on both research protocol and site-specific policies and practices, which would add time and cost to an already delayed trial process. As soon as the site research and patient care levels returned to normal rates or immediate protocol needs were fulfilled, staff would be able to return to regular activities, where funding would revert back to sites, not from sponsors.

The future is still uncertain, and while we don’t know exactly what a “post-COVID-19” world will look like, we do know that sponsors will need to consider trial site networks as partners to continue bringing important therapies to patients in need, both in the aftermath of this pandemic and in preparation for others in the future. Maintaining a thorough site relationship strategy for ongoing programs is part of a more holistic approach to trial design that is proving to be useful during the pandemic and may help shape the future of clinical development.

Vice President, Global Patient and Site Solutions, IQVIA

Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.

Shifting Perspectives on Site Networks to Create Positive Change

Trial resumptions slow as COVID cases rise again

Clinical trials disrupted by COVID-19 are expected to resume at a much slower rate than originally anticipated, as more nations are reinforcing lockdowns due to a globally rising number of COVID-19 cases, says GlobalData.

“The general trend shows a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in trials that are ongoing and recruiting and those that are ongoing but not recruiting,” commented Priya Nair, trials intelligence analyst at GlobalData. “Between Aug. 17 and Sept. 21, ongoing and recruiting trials decreased from 84.7% to 82.2%, while completed trials increased from 4.5% to 6.4%.”

The number of resumed trials increased from over 600 on Aug. 17 to 741 as of Sept. 21. Out of these trials, 82.2% are currently recruiting participants, 7.9% have completed recruitment but are still ongoing, and 0.5% of trials have yet to start recruiting subjects.

GlobalData reports that there is an overall steady increase of trials resuming activity. The U.S. has the highest number of resumed trials at 70.6%, followed by France at 7.6%, the UK and Spain at 7.3% each, and Japan at 7.2%.

“As large numbers of companies shift to alternative ways to conduct trials, it is possible that the use of virtual trials may still be prominent even after the COVID-19 pandemic ends,” said Nair.

Bristol Myers Squibb and MyoKardia, Inc. have entered into a definitive merger agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225 per share in cash. The transaction was unanimously approved by both the BMS and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.

MyoKardia is a clinical-stage biopharmaceutical company that discovers and develops targeted therapies for the treatment of serious cardiovascular (CV) diseases. Through the transaction, BMS gains mavacamten, a potential first-in-class CV medicine for the treatment of obstructive hypertrophic cardiomyopathy (HCM), a chronic heart disease with high morbidity and patient impact. A new drug application for mavacamten for symptomatic obstructive HCM is expected to be submitted to FDA in the first quarter of 2021. BMS expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s pipeline of novel compounds, including two clinical-stage therapies

Genuity Science, a genomics and data insights organization, and Ionis Pharmaceuticals, a company focused on antisense therapeutics, have struck a broad, multi-year collaboration aimed at accelerating the discovery and development of novel therapies across a range of conditions.

Genuity Science’s approach combines high-quality, whole-genome sequence and deep phenotype data resulting in better definition of the underlying disease mechanisms. This approach, when coupled with Ionis’ proprietary antisense technology, has the potential to significantly expedite the drug development process through a more direct translation of targets into drugs. Under terms of the deal, Genuity Science will receive a combination of upfront payments and development milestones, plus product royalties.

Behind its RNA-targeted antisense technology, Ionis has a pipeline of more than 40 drug candidates designed to potentially treat a broad range of disease, including neurological, cardiovascular, infectious, and pulmonary diseases.

PharmaLex Group, a provider of specialized services for pharma, biotech, and medical device industries worldwide, has completed its mergerwith Biopharma Excellence (BPE) GmbH. BPE is a consultancy based in Munich, Germany, which offers specialized biopharma consulting services, including biologicals, antibody-containing products, cell- and gene therapies/ATMPs, biosimilars, and vaccines.

Founded in 2013 by Diane Seimetz, PhD, and Gabriele Dallmann, PhD, BPE supports national and global life science companies from top 10 pharma organizations to emerging startups. The company offers integrated product development services in the EU, the US, and further territories, covering early- and late-stage scientific, regulatory, and strategic support up to submission of dossiers and lifecycle strategies.

News

A compilation of recent notable news developments that pertain to the clinical trials industry.

News Notes (October)

While participation in clinical research offers potential access to promising new treatments, it can also be a challenge for patients due to the burden of trial appointments and the need to travel to a clinical research site that may be far from home. These challenges can become overwhelming, especially if the study participant is seriously ill or is a child. For many study participants, in-home visits from a clinical trial nurse may be a welcome alternative to on-site visits. These in-home visits may also benefit sponsors as they can enhance recruitment and retention without sacrificing data quality, all while increasing patient centricity.

Industry guidelines advise sponsors to reduce the emotional and physical burden of study participation and to consider the convenience of participation for both patients and their caregivers.

With mobile research nursing, a nurse goes to that patient’s home —or any other location that is convenient for the patient—to conduct off-site visits and perform study-related assessments and data collection. These off-site visits ease the burden of study participation by allowing clinical trial obligations to be completed in the comfort of the home and at the convenience of the patient and their caregivers. Bringing the trial to the patient also offers the opportunity to strengthen study engagement, especially if the patient is visited regularly by the same nurse who is familiar with their health and circumstances.

According to the Deloitte Center for Health Solutions, more than 70% of all clinical trial participants live more than two hours away from the clinical research site. The need to travel long distances for frequent follow-up visits may deter eligible patients from enrolling in a study. Offering the attractive option of off-site visits with a mobile research nurse expands the patient population available for recruitment by making study participation accessible even for those with limited mobility and those who do not live near a clinical research site.

 Even the most motivated clinical trial patients may find traveling to sites inconvenient or difficult, especially if they feel unwell. The COVID-19 pandemic and associated travel restrictions have made site visits even more challenging. With mobile research nursing, clinical research visits can be performed where and when it best suits patients and their caregivers.

At Illingworth, we augment our mobile research nursing services with patient concierge services that help patients get to site visits when they are required to do so. These services, which may include travel bookings, expense reimbursements, and other customized features, are uniquely configured to take into account the patient’s specific needs and limitations.

 Reducing the burden of trial participation often goes hand in hand with improving retention. In fact, one survey of clinical trial participants found that 38% of those who dropped out of a study did so because they found site visits to be stressful.

Mobile research nursing contributes to reductions in patient stress without compromising study design or data quality. Indeed, throughout the COVID-19 pandemic, mobile research nursing has enabled patients to continue to participate in clinical trials even when sites were locked down.

 When they need to travel long distances to sites, patients may be exposed to conditions that affect their ability to perform certain physical assessments. Even the disruption of typical routines can impact data quality as patients may become fatigued or exposed to other illnesses while traveling. Mobile research nursing can alleviate these confounding factors by eliminating the need to travel or rearrange daily life activities. In addition, mobile research nursing visits enable site staff to assess the safety of their patients at timepoints when they might not otherwise be able to due to scheduling conflicts or unforeseen circumstances, such as the current coronavirus public health emergency.

Over the past two decades, there has been a significant shift within the clinical research industry regarding inclusion of off-site data acquisition options. This is due, in part, to increasing emphasis on patient-centricity and wider acknowledgement of the patient as a partner in clinical trials—not just as a participant. Researchers today are more likely to engage with patient advocacy groups, and what they are hearing is that patients welcome the opportunity to participate in clinical trials as long as the experience is not overly burdensome. Mobile research nursing helps address that need.

Taken together, the benefits associated with mobile research nursing can help sponsors complete trials on time, with improved recruitment and retention and increased patient and caregiver satisfaction. When the cost of mobile research nursing is balanced against the cost of dropouts and delays, having the ability to offer in-home visits may be appealing to all stakeholders.

With the emergence of COVID-19 and the associated site closures and travel restrictions, many clinical trials came to a halt. Sponsors of existing studies that did not have off-site capabilities turned to mobile research nursing as an option to keeping studies on track. In turn, mobile research nursing providers were tasked with adapting their processes and procedures to ensure the safety of both their nursing staff and study participants. This agility and flexibility in times of uncertainty is invaluable for keeping studies moving forward.

Patients are surrounded by caregivers and families whose lives are also impacted by participation in a clinical trial. On-site visits can put stress on a patient’s support network in terms of time away from home, school, work, and potentially lost wages. In many cases, such as rare diseases, pediatrics, and conditions with limited treatment options, patients and their caregivers will enroll in clinical trials regardless of the inconvenience involved. Participation, however, takes its toll over time.

Technological advances, such as electronic patient reported outcomes, wearables, and telemedicine, have broadened the spectrum of procedures that can now be performed off-site or in the home. With technology, the number of clinical trials that could be conducted with the option of mobile research will continue to increase.

Having a nurse come to the patient eliminates the time a patient, and in some cases their family, would otherwise have to spend traveling and sitting in waiting rooms. Altogether, it makes the mechanics of clinical trial participation less disruptive to a patient’s family life, as well as to their educational and professional lives. Moreover, mobile research nursing offers the patient-centric features of customization and personalization of the clinical trial experience, delivering care in a manner that reflects a patient’s individual preferences and personal situation.

Mobile research nurses are an extension of the team at the study site. A best practice for integration with site staff is to have every nurse approved by the site and named on the delegation of duties log. As these nurses will be performing activities on behalf of the site, it is important for the nurses to engage and build strong relationships with site staff. In-person meetings with site staff are optimal, as this creates opportunities for the mobile research nurses to share their background and expertise. It is also critical to establish a consistent flow of communication between site staff and the mobile research nurses throughout the course of the study.

Another best practice that can help make the clinical trial experience seamless for study participants is for principal investigators (PIs) to discuss the mobile research nursing option and explain how in-home visits will work. Keep in mind that it is entirely up to the patient whether to opt in for mobile research nursing.

A rigorous onboarding process is also essential to successful integration. In an ideal situation, the study participants and their families are invited to meet the mobile research nurse at the clinical research site in advance of the first in-home visit so everyone can become familiar with each other. Of course, adjustments should be made when patients/families cannot travel to the site for these introductory meetings, for example, in the time of a pandemic.

Close communication between the mobile research nurse and the site team to discuss details of the upcoming visit, such as adverse events to follow up on and changes to medication, enhances the quality of care and the nurse’s role as an extension of the site team. Further examples include handling all visit requirements, coordinating with the pharmacy and the courier delivery of the investigational product to the visit location, bringing all equipment necessary to perform the required assessments, and transferring any samples to a courier for delivery to the laboratory. If any serious adverse events are noted, the nurse must immediately report them to the PI and take appropriate action where necessary.

Selecting a mobile research nursing partner

For those exploring mobile research nursing as part of their clinical development plans, here are a few key questions to ask a potential mobile research nursing provider:

Look for providers who offer registered nurses with not only many years of clinical experience, but also specific clinical trial experience in your therapeutic area of interest. You should also ask if the mobile research nursing provider can serve all the geographies where off-site visits may be needed.

2. How are nurses trained to conduct the assessments specified in the protocol in an off-site setting?

The mobile research nursing provider should also have a robust onboarding and training process. In addition to being thoroughly trained in good clinical practice, mobile research nurses should be trained in study-specific procedures.

3. How does the company ensure the quality of the data captured by the mobile research nurse?

Ask about the mobile research nursing provider’s standard operating procedures and the processes they utilize to oversee their nursing staff. Ideally, the provider will prepare and train all nurses on a home care manual that explains all the procedures to be performed at each specific time point. Ongoing data reviews to ensure accurate completion of source documentation with feedback to the nurses enhance data quality and good documentation practices.

The provider should be able to demonstrate a high level of nurse oversight, comprehensive training approach that ensures their nurses can function independently in the field, and a commitment to only hiring nurses who are eager to be integrated into the on-site trial team and dedicated to patient safety and patient centricity.

Fewer than 10% of clinical trials are completed on time. Many studies simply get shelved due to incomplete enrollment. Consequently, study sponsors are continually searching for ways to overcome obstacles in recruitment and retention.

For many, reducing patient and caregiver burden related to clinical trial participation is a top priority.

The rise of mobile research nursing using highly trained practitioners with a diverse skill set harkens back to the bygone doctor’s house call, when care was home-based. Whether at home, school, work, or elsewhere, mobile visits reduce patient and caregiver requirements, providing flexibility and giving study participants more control while addressing key issues for sponsors.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: “Addendum to ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population,” Aug. 18, 2017. Available at 

https://database.ich.org/sites/default/files/E11_R1_Addendum.pdf.

Forte Research: “Retention in Clinical Trials: Keeping Patients on Protocols,” Jan. 23, 2020. Available at 

https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/.

With the assistance of mobile research nursing, in-home visits provide solid alternative to trial participants, especially during COVID-19.

When Trials Stumble, Mobile Research Nursing Lends a Helping Hand

Nearly two-thirds of clinical research sites say they are willing to conduct hybrid or virtual clinical trials, and more than half say they would do “whatever is required” to conduct a virtual study.

 Patients are also eager to participate. In a recent study, 75% of patients say that collecting all study data from their own home is appealing and 73% like the idea of a hybrid trial.

While the convenience, speed, and potential data quality improvements that come with decentralized clinical trials (DCTs) are inspiring, implementing DCTs can seem intimidating to investigators who haven’t participated in largely virtual studies.

“Consider how to embrace DCTs in a way that creates opportunity for your site and your patients. We must innovate to meet patient needs,” said Amanda Wright, vice president of partnership development at Javara, an integrated research organization that, in partnership with Wake Forest Baptist Health, is working on a Phase III clinical research study to evaluate the safety and effectiveness of mRNA-1273, a vaccine candidate against COVID-19 sponsored by Moderna. “You don’t have to decentralize every element of every study. Start where you’re comfortable. Carefully evaluate which components of each study can be decentralized, such as using remote monitoring devices to collect vitals such as weight and blood pressure without an in-person visit.”

With proper evaluation and planning, sites can avoid unexpected obstacles and reap the benefits of a DCT. Here are five key considerations to enable an easier transition to decentralized research.

1. Change management: Know what to expect

DCTs do not mean studies are entirely virtual, and often follow a hybrid model that leverages digital technologies like eConsent, telemedicine, wearable devices, electronic clinical outcome assessments (eCOAs), and electronic health (eHealth) records for various parts of the process. These technologies can improve patient centricity by reducing the burden of in-person visits and manual activities like paper diaries. Additionally, DCTs provide patients with interpersonal reassurance and support with technology to enable interactions at a time and place that suits patients and caregivers, which often leads to a better-quality interaction.

The obstacles to DCTs for sites range from fear of irrelevance, difficulty transitioning from paper to technology, the potential for patient resistance, patient populations without access to the internet, and concerns about data security and privacy.

Sites can overcome those challenges to improve outcomes and experience for all stakeholders. DCTs benefit sites by providing

Expanded trial access and diversity of participants

Improved patient engagement and retention

Expedited patient identification and cost reduction

Increased capacity for additional studies

As sites become more comfortable with DCTs, they may realize that DCTs can actually enable a closer patient-physician/site relationship than a traditional, randomized clinical trial can. DCTs enhance the patient-physician/site relationship in a virtual world by providing modular options and more choices.

Even so, a thorough change management process is imperative. Map out the options best for your site and include those that are already part of your infrastructure (see Figure 1 below). When creating messaging to staff and patients about the new options, for example, reinforce that it is an opportunity to ease burden and improve the workflow for everyone. Highlight to study teams, investigators, and patients that there will be choices about how to participate in a study.

“Preparation is key. You may need to customize your strategy for subgroups that are less comfortable with technology. It’s also imperative to understand your population’s access to the internet. This will help inform your search for the right technology partner and your implementation plan,” explained Patricia S. Larrabee, founder and CEO at Rochester Clinical Research. “Staff will be excited that data collection is faster, in real-time, and that the risk of losing paper documents will diminish. Televisits are not without challenges, but they have allowed us to continue studies during the pandemic. We always need to be ready to see patients remotely and sometimes after hours, particularly to assess adverse reactions. DCTs make it possible.”

2. Technology:What to look for in partners and solutions

There are several technology solutions in the marketplace, so it can be challenging to evaluate what is best for each individual organization. Of course, a DCT technology solution must support principal investigators in managing the care and safety of patients, but what else should be considered? Should it be an end-to-end product that covers all your technology needs? Does the solution accommodate hybrid studies? What is important to look for in the user interface?

Typically, there’s no need to do a complete technology overhaul. The best approach is to integrate all systems, including existing systems, and ensure your primary solution is built modularly. It allows sites to customize which studies, or parts of a study, to decentralize, as not every site or patient is ready to digitize every element of the process. As critical, the platform must seamlessly integrate with wearables and patient-collected data.

“No one needs one more piece of technology that doesn’t talk to your other systems; it needs to integrate,” said Larrabee. “And even more so, it should not require a software engineer to use it.”

When it comes to ensuring patient centricity, opt for a solution that has a simple, single sign-on to provide patients with ‘one way in and one way out,’ as Wright suggests, to minimize the learning curve. This will also significantly reduce tech support burdens for sites. Another important consideration for patients is internet access. Look for a system and provider that can meet the needs of participants without consistent internet access. For example, some DCT vendors provide devices that can work as hot spots.

In addition to the technology itself, consider the provider. For example, the vendor’s product development efforts should be informed with input from sites, such as a core bench of site advisors, so product development does not take place in a vacuum. For example, sites say that redundant questions are a significant pain point of inefficiency. So platforms that incorporate such feedback into forms, workflows, product ideation, and other areas will yield greater success. Similarly, technology providers should have a patient advisory council that provides input to product development and participates in user testing.

“The vendor should demonstrate that product design and user testing included patients of all ages and technical abilities. We must not assume that all patients have internet access or smart phones with data plans. Trials need diverse participants, so we must be able to include those without access to internet or their own technology. A technology vendor who addresses that is key,” noted Larrabee. “We also want partners who understand the site perspective. Make sure you have a chance to try using the solution before making a final commitment to ensure it really does what they say it does. Finally, the solution must be HIPAA compliant.”

3. Charting the course: Planning and training

The recommendations provided by the Clinical Trials Transformation Initiative (CTTI)

, a public-private partnership co-founded by Duke University and the FDA, are an important foundation when creating your implementation plan and training. The recommendations cover topics such as protocol design, state-level telemedicine issues, drug supply chain, mobile healthcare providers, investigator delegation and oversight and safety monitoring.

Early in the process, it is critical to map out a plan for general implementation that includes a thorough training process for staff and patients. It’s essential that training goes beyond feature and function to incorporate the “why’s” for staff and patients. With any new process, understanding the why’s and how each person benefits helps to ensure success. Since coordinators will be a source of tech support for patients, establish a “super user” at each location.

Many sites have found that DCTs offer flexibility for staff to work from home on occasion. Mapping out work-from-home standards that align with security and privacy regulations may seem daunting, but many have found that the added flexibility helps retain valuable team members. And documentation provides everyone involved with the reassurance they need to embrace new processes and technology.

Be sure to carefully craft messaging for patients about the security and privacy of information. The message should reflect patients’ cultural sensitivities. For example, in some countries, patients may have fears about items such as images of a medication being stored on their mobile device. Real-time information also means real-time responsibility. Therefore, structures need to be in place for responding to data collected through the technology and it may require new decision-support processes—experienced DCT technology providers can help map this out.

“Update your operating procedures, job descriptions, and performance criteria accordingly to ensure tech proficiency,” added Larrabee. “Listen to the end users, appoint several champions, give them time to learn it, and most of all, make sure they can see the big picture. Make it work by listening and responding to their needs.”

4. Guiding principle: Patients drive process

Patient centricity is a common term today, but making sure patients are at the center of DCT processes and technology is the key to success. Considerations for patient safety, patient engagement, and logistics are all part of the equation. Here’s how to keep that commitment.

Patients need the ability to choose which elements of a study they wish to do remotely and which they prefer to do in person. Since one size does not fit all, modular flexibility is so important. There must be choices for patients—and physicians/sites. Platforms with an interface that mirrors consumer technology like Amazon or Google also go a long way in helping patients feel comfortable.

“This is an opportunity to reach patients we otherwise could not, and patients want choices,” agreed Wright. “Patient experience and engagement is critical to the success of any trial. The better your patient’s experience, the more likely they will participate in another trial or refer a friend or family member, too.”

Larrabee continued, “Our focus on patient experience can’t end at the in-person encounter. The technology we use to interact with patients and the way we use it, needs to reflect the same standards we adhere to for all other aspects of the patient experience.”

5. Cycle of improvement: Measure and adjust

As with any business process, the utilization of DCTs must continuously improve. However, as DCTs continue to evolve, the patient feedback loop is exponentially important. Surveying patients is a great start, but the industry also needs to respond to feedback with meaningful change with each new lifecycle.

DCT technology innately enables ease of information flow to make better clinical decisions. Measure operational and patient/staff experience results regularly—to both collect feedback and to have quantifiable metrics to evaluate against the next time. For example, one investigator site implemented a digital data collection tool to increase efficiencies for both patients and staff. Patients no longer had to fill out a handwritten document, go to the site, and turn it in. Staff were able to see the patient responses in real-time in the app instead of transcribing in writing from the patient’s paper document. Their patient experience survey results were excellent, with the majority rating as very good/good.

“Efficiency is key. We measured the efficiency of regulatory document submission and found an increase in speed of 50% by going digital in just that one area,” concluded Larrabee. “Service is important in our industry. Listen, listen, and listen more. Encourage your staff to give feedback as well; we are all still learning.”

Change can be difficult, but a transformation that eases the burden of trial participation on patients and enhances so many other aspects of clinical trials is more than worthwhile. No two sites or patients are the same. The industry must continue to listen to its constituents and strive to meet the challenges of diverse communities. As these experts have explained, things are evolving and far from perfect, but through collaboration and insights from all stakeholders, we can enhance the access, data quality, and efficiency of clinical research.

Milam, D., “Hybrid Decentralized Trials: Using Technology to Create More Patient-Centric Studies,” 

https://www.clinicalleader.com/doc/hybrid-decentralized-trials-using-technology-to-create-more-patient-centric-studies-0001

Tufts Center for the Study of Drug Development, “Rising protocol complexity is hindering study performance, cost, and efficiency,” Impact Report, Volume 20, Number 4, (July/August 2018). See full resource: 

https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5b4de76e352f53bd7a416e1b/1531832174796/julaug-summary.pdf

Holland, A., “The Centricity of Decentralizing Risk-Based Clinical Trials.” 

Volume 34, Issue 7, (August 2020). See full resource: 

https://acrpnet.org/2020/08/10/the-centricity-of-decentralizing-risk-based-clinical-trials/

Tenaerts, P. and Randall, P., “Overcoming Barriers in Conducting Decentralized Clinical Trials,” 

https://www.appliedclinicaltrialsonline.com/view/overcoming-barriers-conducting-decentralized-clinical-trials

Head of Site and Investigator Networks, Medable

Decentralized clinical trials (DCTs) have ignited clinical transformation while the COVID-19 pandemic has fueled their rapid expansion.

Five Tips to Help Research Sites Implement Decentralized Clinical Trials

It was around the spring equinox this year that the COVID-19 challenge really started to bite in Europe. Now, just after the autumn equinox, Europe is still a long way from finding vaccines to fight back—as a hearing in the European Parliament on Sep. 23 confirmed. Industry representatives made reassuring noises about progress with candidate vaccines, but recognized that there was no guarantee of success in their efforts, and it would be next year—at best—before any real response would be available. Officials from the European Medicines Agency (EMA)—which has to approve any vaccine before it can be used in Europe—confirmed, as of late September, that they had as yet received no data from any of the companies developing vaccines in Europe. And members of parliament anxious to check on industry progress were left dissatisfied or disappointed.

In particular, the hearing focused on the deals that drug firms are reaching with European authorities, in which companies are receiving billions of euros to speed up the development and production process, in return for commitments to supply the EU with specified quantities of vaccines. Members of European Parliament (MEPs) wanted to make sure that drug firms were not being given a blank check from public funds, while charging what they wanted for their products and dodging responsibility for any side effects.

“Is Europe getting value for money from the arrangement,” they questioned. “When can EU citizens expect safe and effective protection to be delivered?”

The answers—from senior executives of Sanofi, CureVac, and the vaccine industry’s European trade body—did not go far enough for the chairman of the parliament’s health committee, Pascal Canfin. “Today, we have very little information on the content of the contracts that have been signed by the European Commission and some laboratories,” he said at the end of the hearing. “We wanted to have more information on the state of research, the commitments made by laboratories, and whether they will be able to meet them. We do not even know how many of these contracts there are.” And like many of his fellow MEPs, he accused the industry and the European authorities of a lack of transparency.

German socialist Tiemo Wölken, an influential MEP in health matters, cited allegations that the industry was demanding unprecedented liability exemptions and wanted to know why the contracts—and all the details of prices and costs and criteria and milestones—were being guarded so secretively. It was, he said, an issue of trust on a matter of massive public interest. His approach was echoed widely by other MEPs during the two-hour session.

There were some answers. “Everyone will have the right to have the data—transparency will be there,” said Jean Stéphanne, board chairman of CureVac, which is in the final stages of agreeing a contract with the EU. But, he insisted, not yet.

Thomas Triomphe, EVP of Sanofi Pasteur, which has signed a contract to provide 300 million doses of its recombinant protein technology vaccine combined with an adjuvant provided by GlaxoSmithKline, currently in Phase I/II trials, said, “Our price will be made public.” He also said that costs will also be revealed. But they will be disclosed later, only when it becomes clear what the dosage is for the vaccine.

“We understand the interest in the details of the contracts,” said Sue Middleton, president of the industry association Vaccines Europe. But, she said, there are issues of competition that must be respected until all the contracts are complete. “There are commercial confidentiality reasons for the details not at present being in the public domain,” she said. Since the European Commission has already indicated that prices will be in the range of €5 to €15 (about $6 to $18 USD) a dose, that is sufficient for the moment, she added, and “it is right” that the exact prices are not yet available.

On responsibilities, Middleton told MEPs that manufacturers are liable if there is deliberate misconduct or good manufacturing practice violations, but for unexpected events in large populations there will be indemnification by the European Commission or member states on the costs of legal action.

phanne added that without liability protection, there would be “no chance of vaccine development.”

Canfin concluded the hearing by stating that his committee would be coming back to industry with a detailed list of further questions. It is starting to look increasingly like it may be the next spring equinox before much clarity emerges on Europe’s vaccine hopes.

 is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

View from Brussels

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

Europe's COVID Vaccine Bids Still Veiled in Secrecy

Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. One aim of such extensive disclosure of research methods is to address fears that a push for speedy results from the White House might lead to FDA authorization or approval of a COVID vaccine before Phase III data has been fully evaluated. Regulatory authorities and industry leaders have loudly proclaimed their adherence to good science, and vaccine sponsors pledged to collect sufficient data to demonstrate product safety and efficacy before seeking FDA approval. But the debate continues.

Several recently issued research protocols specify numbers of participants in the late-stage clinical trials, age and sub-group goals, enrollment procedures, plans for blinding, randomized assignment to placebo, and efficacy assessments. Details include dosing schedules and adverse event assessments.

Moderna CEO Stephane Bancel led the move toward greater transparency in August by issuing the 

135-page plan for its study for mRNA-1273 SARS-CoV-2 vaccine

. It specified that an independent data monitoring committee is slated to compare efficacy of vaccine to placebo initially when 53 and 106 cases are confirmed, and then after 151 cases of infection. With two doses of the vaccine needed to achieve desired immunity, Moderna says it does not expect full study results until late November.

Pfizer and AstraZeneca similarly released detailed trial protocol documents, acknowledging the need for greater transparency in COVID vaccine research. Pfizer specifies the vaccine candidate and dose for Phase II/III testing and that it expects to assess nearly 44,000 participants, with half receiving the vaccine. 

The expectation is that this will yield 164 primary-endpoint cases within six months

AstraZeneca’s protocol indicated that statistical confidence will be met when 150 trial participants become ill.

 The plan calls for only one interim analysis, and that the trial might be halted early if the vaccine shows effectiveness with fewer cases of contamination. However, AstraZeneca’s timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. Although the sponsor resumed its vaccine trials in the UK, Brazil, and South Africa, US testing remained on hold as officials at the National Institutes of Health (NIH) moved to investigate further the cause and nature of the adverse event and whether it was triggered by the vaccine or an unhappy coincidence. US authorities were concerned that the sponsor failed to reveal specifics on the safety issue, which outside clinicians identified as the rare spinal inflammatory disorder transverse myelitis.

In launching its Phase III ENSEMBLE study a few weeks later for its vaccine candidate, Johnson & Johnson’s Janssen unit also unveiled its 

 to assess its recombinant adenoviral vector vaccine in 60,000 participants, with 30,000 receiving a placebo. A main advantage of this shot is that it only requires one dose, which stands to accelerate the testing and data analysis process considerably. J&J will monitor trial participants until 154 COVID-19 related events occur to assess whether the vaccine provides sufficient protection against COVID-19.

Novavax announced on Sept. 24 that it, too, had initiated its first 

 to evaluate its COVID-19 vaccine candidate, which has demonstrated high potency in early testing. It is being first tested in 10,000 volunteers in the UK, with plans for a second 30,000-patient study in the. At that time, the company said it planned to publish its UK study protocol to support transparency. Its initial announcement indicated that this first study has two primary endpoints, as compared to one for other vaccine trials, which may increase the time needed to demonstrate efficacy in moderate or severe disease.

The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence. Although vaccine study sponsors had provided the usual public information on study sites and enrollment plans, more details on statistical analysis efforts should facilitate outside assessment of decisions by sponsors to seek input from independent data safety monitoring boards or to stop a trial early. And with the US government providing billions in support of most of these vaccine development programs, independent scientists believe the public has the right to such information.

View from Washington

Sponsors are beginning to make their study protocols public as pressure for a COVID-19 vaccine rises.

COVID Advances Clinical Trial Transparency

Let’s take a short vocabulary quiz. Full in-person, hybrid, virtual, remote, synchronous, asynchronous are terms used for, a) descriptions of clinical trials, b) types of cars, c) descriptions of learning models for schools during COVID-19. The answer is “c,” but the comparison I was going for is clearly trial design or type of site model. I left out decentralization because that would have been a huge giveaway, and I haven’t seen that term used yet on any school K-college curriculum. While I struggled with understanding synchronous and asynchronous as the two forms of online learning in the beginning, I have it down now. There has been a lot of discussion in clinical trials about the difference between virtual and remote, and I think that has been cleared up also. So let’s dive into the future of hybrid, decentralized, and remote trials.

According to a recent report from Frost & Sullivan, 

“Hybridization of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019-2024,” 

hybrid trials and remote patient monitoring are key trends driving the global CRO market. While COVID-19 may in and of itself be a driving force behind the adoption of both hybrid trials and remote patient monitoring, it is also putting downward pressure on the overall CRO market. The company’s analysis suggested that the current ongoing trial disruptions are effecting revenues for the short-term. Frost & Sullivan further expects that revenue will be back to its original growth trajectory by 2024–2025, with a compound annual growth rate of 8.2% and $63.83 billion revenue by 2024, up from $43.03 billion in 2019.

ACT's Editor-in-Chief, Lisa Henderson, assesses the sustainability of remote trials.

Applied Clinical Trials-10-01-2020